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Application of Electrically Driven Atomized Surface Anesthesia in ATI in Patients With Predictably Difficult Airway.

Application of Electrically Driven Atomized Surface Anesthesia to Awake Endotracheal Intubation in Patients With Predictably Difficult Airway.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06420947
Enrollment
230
Registered
2024-05-20
Start date
2024-09-05
Completion date
2025-02-05
Last updated
2025-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Endotracheal

Keywords

Lidocaine atomized particles, Nebulization, Awake tracheal intubation, Individual topicalization technique

Brief summary

This is a parallel and randomized-controlled clinical study aimed to identify the optimized size of atomized particles of 2% lidocaine that can provide the best topical anesthesia during ATI. To determine the effect of nebulization with different sizes of atomized particles of 2% lidocaine on cough, reaction, and comfort during ATI in patients with predicted difficult airway.

Interventions

Participants received 2% lidocaine by atomizer.

Sponsors

Henan Provincial People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Patients with distinctly difficult airways:(1) Patients with medical history indicating difficult airways.(2) Patients suffering from severe burn scars.(3) Patients suffering from severe obstructive sleep apnea syndrome.(4)Patients suffering from severe congenital dysplasia. Patients with suspected difficult airway: Patients with risk factors underwent a medical history for evaluation:(1)Patients with ankylosing spondylitis.(2) Patients with rheumatoid arthritis.(3)Patients with degenerative osteoarthritis.(4)Patients with epiglottitis. (5)Patients with acromegaly.(6)Patients with morbid obesity.(7)Patients with subglottic stenosis. (8) Patients with enlarged thyroid or tonsils.(9)Patients with mediastinal mass.(10)Patients with throat tumors. Patients with risk factors underwent a physical examination for evaluation:(1)Patients with BMI \> 26 kg/m2. (2)Patients with Mallampati class 3 or 4. (3)Patients with thyromental distance\<60 mm (corresponding to an average distance of 3 finger breadths).(4)Patients with limited mouth opening with interincisor distance\<30 mm.(5)edentulous patients.(6)When the patient closed his mouth in a natural state, the upper incisor was situated in front of the lower incisor.(7)When the mandible is extended forward, the lower incisors of the patient can not protrude beyond the upper incisors.(8)The patient's jaw exhibits stiffness, with minimal elasticity or presence of a tumor.(9)The patients have a short neck with a thick circumference.(10)The patients are unable to touch their chest wall with their jaw, or extend their neck.(11)The patients's palate shape is either characterized by a high arch or is extremely narrow.

Exclusion criteria

(1) refusal to participate in the study; (2) airway bleeding; and (3) known allergies to local anesthetics. \-

Design outcomes

Primary

MeasureTime frameDescription
cough scoreduring intubationInvestigators will record cough score during intubation.

Secondary

MeasureTime frameDescription
reaction and discomfort scoresduring intubation.Investigators will record reaction and discomfort scores during intubation.
intraoperative hemodynamic parametersendotracheal tube insertion, inflation of the tracheal tube cuff and 1 minute after endotracheal tube insertionendotracheal tube insertion inflation of the tracheal tube cuff systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026